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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes

2012年1月10日 更新者：Novartis

A Multi Center, Randomized, Double Blind, Placebo-controlled, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 Administered Intravenously to Patients With Type 2 Diabetes Mellitus

The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose levels in response to an oral glucose tolerance test (OGTT).

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

231

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Arkansas
      • Little Rock、Arkansas、アメリカ、72202
        • Arkansas Research Medical Testing
    • Florida
      • Miami、Florida、アメリカ、33169
        • Allied Research International - Cetero Research Miami
      • Miami、Florida、アメリカ、33169
        • Elite Research Institute Miami
    • Maryland
      • MD、Maryland、アメリカ、21286
        • International Research Center Towson
    • Oregon
      • Portland、Oregon、アメリカ、97239
        • Covance Clinical Research Unit Inc
    • Washington
      • NW Tacoma、Washington、アメリカ、98418
        • Charles River Clinical Services
  • ドイツ
      • Berlin、ドイツ
        • Novartis Investigator Site
      • Kiel、ドイツ
        • Novartis Investigator Site
      • Moenchengladbach、ドイツ
        • Novartis Investigator Site
      • Munich、ドイツ
        • Novartis Investigator Site
      • Neuss、ドイツ
        • Novartis Investigative Site
  • ロシア連邦
      • Moscow、ロシア連邦
        • Novartis Investigative Site
      • St. Petersberg、ロシア連邦
        • Novartis Investigative Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～70年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Male or female patients aged 18 to 70 years, with type 2 diabetes mellitus (non-insulin dependent diabetes) for at least 6 months prior to study start
  • HbA1c between 7.0 and 9.5%
  • On stable dose metformin monotherapy
  • Stable body weight

Exclusion Criteria:

  • Poorly controlled type 2 diabetes (very low or very high blood sugar levels, or other indicators of poor control)
  • Acute infections prior to dosing
  • Patients with type 1 diabetes (insulin-dependent diabetes)
  • Taking diabetes medication (other than metformin)

Other protocol-defined inclusion/exclusion criteria may apply

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Canakinumab

Eligible participants were assigned to receive canakinumab in one of four cohorts; 1) Single IV infusion of canakinumab 0.3 mg/kg; 2) Singe IV infusion of canakinumab 10 mg/kg; 3) single IV infusion of canakinumab 0.1 mg/kg or 0.3 mg/kg, or 1.5 mg/kg; 4) Single IV injection of canakinumab 0.03 mg/kg.

All participants were required to take a concomitant stable daily dose of metformin during the study.
薬：Canakinumab
Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.
他の名前：
  • ACZ885
薬：Metformin
Participants continued on their stable daily dose of metformin throughout the study
他の名前：
  • グルコファージ
  • グルメツァ
プラセボコンパレーター：Placebo

Eligible participants were assigned to receive placebo to canakinumab in one of four cohorts; 1) Single IV infusion of placebo to canakinumab 0.3 mg/kg; 2) Singe IV infusion of placebo to canakinumab 10 mg/kg; 3) single IV infusion of placebo to canakinumab 0.1 mg/kg or 0.3 mg/kg, or 1.5 mg/kg; 4) Single IV injection of placebo to canakinumab 0.03 mg/kg.

All participants were required to take a concomitant stable daily dose of metformin during the study.
薬：Metformin
Participants continued on their stable daily dose of metformin throughout the study
他の名前：
  • グルコファージ
  • グルメツァ
薬：Placebo
Placebo to Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mean Change From Baseline in Plasma HbA1c (Glycosylated Hemoglobin / Hemoglobin A1c)
時間枠：Baseline, Day 28, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)
Blood was drawn after an overnight fast to measure plasma HbA1c levels. End of Study is defined as the last Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 28, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)
Mean Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 - 4 Hours Following Oral Glucose Tolerance Test (OGTT )
時間枠：Baseline, Day 28, Day 84
Mean Change in Glucose level stimulated by OGTT. Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Glucose levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 28, Day 84

二次結果の測定

結果測定
メジャーの説明
時間枠
Mean Change From Baseline in Plasma C-peptide AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test (OGTT)
時間枠：Baseline, Day 28, Day 84
Blood samples were drawn after an overnight fast and standard OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. C-peptide levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 28, Day 84
Mean Change From Baseline in Plasma Insulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )
時間枠：Baseline, Day 28, Day 84
Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 28, Day 84
Mean Change From Baseline in Plasma Proinsulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )
時間枠：Baseline, Day 28, Day 84
Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 28, Day 84
Mean Change From Baseline in Plasma Glucagon AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test
時間枠：Baseline, Day 28, Day 84
Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Glucagon levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 28, Day 84
Mean Change From Baseline in Peak Plasma Insulin/Proinsulin Level, Following Oral Glucose Tolerance Test (OGTT)
時間枠：Baseline, Day 28, Day 84
Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin and proinsulin levels were measured. The insulin/proinsulin level was calculated by dividing the insulin level by the proinsulin level. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 28, Day 84
Mean Insulin Secretion Rate ( ISR ) Relative to Glucose, 0 - 4 Hours
時間枠：Day 28, Day 84

Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Mean ISR relative to glucose over 0-4 hours was calculated as follows:

Mean ISR relative to glucose = mean ISR / (glucose AUC/time interval). The mean ISR was computed as an AUC (area under the curve) using the linear trapezoidal rule divided by the corresponding time interval. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Day 28, Day 84
Mean Insulin Secretion Rate ( ISR ), 0 - 4 Hours
時間枠：Day 28, Day 84
Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. The mean ISR over 0 - 4 hours was computed as an AUC (area under the curve) using the linear trapezoidal rule divided by the corresponding time interval. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Day 28, Day 84
Insulin Sensitivity Index ( ISI ) at Day 28, Day 48
時間枠：Day 28, Day 84
Insulin sensitivity index (ISI) = 10000 / [fasting insulin (μIU/mL) x fasting glucose (mg/dL) x mean 2 hour insulin(μIU/mL) x mean 2 hour glucose (mg/dL)]1/2 where mean 2 hour insulin (or glucose) was defined as the insulin (or glucose)AUC(0-2 hr) divided by the time period (2 hr). In normal subjects the mean score ± SE is 0.366 ± 0.029. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.
Day 28, Day 84
Insulinogenic Index, 0 - 30 Minutes
時間枠：Day 28, Day 84

Insulinogenic index (0-30 min)

  • [Change in insulin (0-30 min) (μIU/mL)] / [Change in glucose (0-30 min) (mg/dL)]
  • [insulin (μIU/mL) at 30 min - insulin (μIU/mL) at 0 min] / [glucose (mg/dL) at 30 min - glucose (mg/dL) at 0 min), where insulin (or glucose) at 0 min was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data..
Day 28, Day 84
Mean Change From Baseline in Peak Plasma Glucose Following Oral Glucose Tolerance Test ( OGTT )
時間枠：Baseline, Day 28, Day 84
Mean Change in Peak Glucose level stimulated by OGTT. Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Change from baseline assessed at Day 28 and 84. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 28, Day 84
Mean Change From Baseline in Peak Plasma Fructosamine Level
時間枠：Baseline, Day 14, Day 28, Day 56, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)
Blood was drawn to measure change in plasma Fructosamine Level, from baseline to Day 14, 28, 56, 84, 126 and End of Study ( defined as the final available post-randomization assessment up to the last regularly scheduled visit at Day 168 [+/- 5]). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 14, Day 28, Day 56, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)
Insulin Resistance as Measured by the Homeostatic Model Assessment (HOMA-IR)
時間枠：Baseline, Day 28, Day 84
Insulin Resistance is measured via the Homeostatic Model Assessment (HOMA-IR) using a computer to model insulin sensitivity. Insulin Sensitivity (HOMA-%S), where 100% is normal, is the reciprocal of insulin resistance (100/S%). HOMA IR = [fasting insulin (μU/mL)] x [fasting plasma glucose (mmol/L)] / 22.5 where fasting insulin (or glucose) was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.
Baseline, Day 28, Day 84
β-cell Function as Measured by the Homeostatic Model Assessment (HOMA-β )
時間枠：Baseline, Day 28, Day 84
β cell function is measured by the Homeostatic Model Assessment(HOMA-β) using a computer to model β cell function and insulin sensitivity . β cell function is related to Insulin Sensitivity (HOMA-%S) and is the reciprocal of insulin resistance (100/S%). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5] where fasting insulin (or glucose) was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.
Baseline, Day 28, Day 84
Number of Participants Reporting Death, Serious Adverse Events (SAEs), Adverse Events (AE) Above 5% Frequency
時間枠：Baseline to End of Study (56[+/-2] and 168 [+/- 5] days after dosing for Cohort 1 and Cohorts 2-4, respectively)
An adverse event is any unwanted event, whether related to study drug or not occurring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit.
Baseline to End of Study (56[+/-2] and 168 [+/- 5] days after dosing for Cohort 1 and Cohorts 2-4, respectively)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Novartis

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2007年12月1日

一次修了 (実際)

2010年9月1日

研究の完了 (実際)

2010年9月1日

試験登録日

最初に提出

2008年1月18日

QC基準を満たした最初の提出物

2008年1月30日

最初の投稿 (見積もり)

2008年1月31日

学習記録の更新

投稿された最後の更新 (見積もり)

2012年2月13日

QC基準を満たした最後の更新が送信されました

2012年1月10日

最終確認日

2012年1月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CACZ885A2213

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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